Bronze part from a equipment

GOOD VALIDATION PRACTICE (cGVP) EQUIPMENT VALIDATION
1

Hello,

I am Braian, I am Engineer and I am working in a pharmaceutical industry as validation specialist. I have been working on a qualification (IQ) of an Encapsulation Machine; in it is a part in contact with the product that is made in Bronze instead of stainless steel (its a station to put the pellets in the capsule). Is it correct, a part made in bronze in that kind of equipment is in contact with the product? :confused:

Thanks in advanced

2

It is very important that you change it to a non reactive well polished stainless steel material.
Bronze is an alloy made of copper and another metal, usually tin. Compositions vary, but most modern bronze is 88% copper and 12% tin.
Most of these materials are reactive to vitamines and they also react with other APIs and excipients in usage.

The bad part of Bronze is it is brittle and over period of time it gets oxidized and turn into a green or dark brown in color.

Get it replaced immediately or else regulatory auditor might see and becomes a major observation.

3

Thank you Durga Prasad.

Do you have a specific reference (from a regulatory organisation) where I can find the information related with this topic? I need to do the reference in my protocol. Would you mind let me know about it?

Thanks in advanced.

4

[COLOR="#000000"]SUBCHAPTER C–DRUGS: GENERAL

PART 211 – CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS

Subpart D–Equipment

Sec. 211.65 Equipment construction.
(a) Equipment shall be constructed so that surfaces that contact components, in-process materials, or drug products shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements.

(b) Any substances required for operation, such as lubricants or coolants, shall not come into contact with components, drug product containers, closures, in-process materials, or drug products so as to alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements.[/color]